Phase II, Multi-Centre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection, of Three Doses of Dysport (40 Units/Eye, 80 Units/Eye, and 120 Units/Eye) for the Treatment of Benign Essential Blepharospasm

Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment.

Change from baseline in BDS, FIM, severity of oculo-facial spasm and in severity of global impairment due to blepharospasm (measured by VAS) at 4, 8, 12 and 16 weeks post treatment.

Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.

Patient assessment of benefit and need for re-treatment, evaluated at the end of the study.

Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study.

To compare the safety of each of the 3 doses of Dysport with placebo in terms of adverse event incidence, vital signs and physical examinations.

Estimated Enrollment:

120

Study Start Date:

January 2003

Estimated Study Completion Date:

May 2004

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

patients with a confirmed diagnosis of bilateral benign essential blepharospasm, and having symptoms of such for at least 6 months prior to the baseline visit

naïve patients to botulinum toxin type A treatment, or patients who had received a single treatment of botulinum toxin type A, or those who had demonstrated a satisfactory response, in the investigator's opinion, to the last 2 injections of botulinum toxin type A with a minimum of 12 weeks since the last injection and where a further injection at full dosage was now indicated

patients with a minimum score of 8 on the BDS

Exclusion Criteria:

patients with either neuroleptic-induced blepharospasm, isolated levator dysfunction or apraxia

previous surgical, chemical and thermal myectomy or neurectomy

any condition where intramuscular injection is contraindicated

ophthalmolgical infection

myasthenia gravis or other disorders of the neuromuscular junction

prescription of antispastic, muscle relaxants or medications affecting neuromuscular junction transmission, or medication where the dose or choice of medication has not been constant for the last 30 days

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234507